Pharmaceuticals 101 Flashcards
The FDA is responsible for assuring that _____ are both safe and effective. Select all that apply
Prescription drugs
Over-the-counter medications, such as fluoride
Cosmetics
Sunscreen
Prescription drugs
Over-the-counter medications, such as fluoride
Cosmetics
Sunscreen
The center for Drug Evaluation and Research (CDER) regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.
True
False
True
Pharmaceutical companies are licensed by the ____ to sell prescription and over-the-counter (OTC) generic and/or brand medications and medical devices.
CDER
FDA
NDA
GMP
FDA
The study of how the body affects a specific drug after it has been administered is known as:
Bioavailability
Pharmacokinetics
Toxicity
Discovery
Pharmacokinetics
Clinical Trials conducted on animals occurs during which phase of R&D?
Pre-clinical Phase
Phase I
Phase II
Phase III
Pre-clinical Phase
Which of the following is a driver for how a pharmaceutical company creates it R&D strategy?
Select all that apply.
Regulatory factors
Clinical factors
Market size
Business opportunity
Regulatory factors
Clinical factors
Market size
Business opportunity
Double-blind, placebo-controlled studies are conducted during which phase of clinical development?
Pre-clinical phase
Phase I
Phase II
Phase III
Phase III
505(b)(2) NDAs are submitted by pharmaceutical companies that have conducted the necessary clinical trails or purchased data from studies done by a contract research organization
True
False
False
Which of the following are FDA drug approval pathways?
Abbreviated New Drug Application (ANDA)
New Drug Application (NDA)
Over-the-counter (OTC) Monograph
All the above
All the above
Select the following pieces of information included in the highlights section of a PI. Select all that apply
Indications and Usage
Dosage and Administration
Contraindications
Drug Interactions
Indications and Usage
Dosage and Administration
Contraindications
Drug Interactions
The FDA guidelines that govern the manufacture of pharmaceuticals products are known as:
GMPs
GPPs
NDAs
INDs
GMPs
Which type of pharmacy typically sells high-cost, injectable medications and distributes products directly to healthcare professionals, home health agencies, or patients
Retail Pharmacy
Specialty Pharmacy
Hospital Pharmacy
Wholesale Pharmacy
Specialty Pharmacy
In the US, Which of the following groups are required to report adverse events to the FDA? Select all that apply.
Patients
Healthcare Professionals
Manufacturers
None of the above
Manufacturers
____ is the transference of a prescription drug from the person to whom the drug was originally prescribed to another individual for the purpose of nonmedical use.
Misuse
Diversion
Abuse
Addiction
Diversion
Prescription Drug Monitoring Programs (PDMPs) were developed to promote public health and welfare by detecting diversion, abuse, and misuse of prescription medication under individual state law.
True
False
True
